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RECRUITING

NCT06981390

Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

Sponsor: Kexiang Liu, MD

View on ClinicalTrials.gov

Summary

This randomized controlled trial aims to evaluate the impact of different durations of Ticagrelor-based dual antiplatelet therapy (DAPT) on saphenous vein graft (SVG) patency in patients undergoing coronary artery bypass grafting (CABG). A total of 300 patients will be randomly assigned to receive Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, 6 months, or 12 months, followed by aspirin monotherapy.The primary outcome is 1-year graft patency, assessed via coronary CT angiography. Secondary outcomes include bleeding events (BARC classification), major adverse cardiovascular and cerebrovascular events (MACCE), and all-cause mortality. The study aims to determine the optimal DAPT duration to balance graft patency benefits and bleeding risks, ultimately guiding postoperative antiplatelet strategies for CABG patients.

Official title: Ticagrelor-Based Dual Antiplatelet Therapy in Coronary Artery Bypass Grafting: A Randomized Clinical Trial on Graft Patency

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-02-01

Completion Date

2026-03-20

Last Updated

2025-07-23

Healthy Volunteers

Yes

Conditions

Coronary Artery Disease Coronary Artery Bypass Grafting Saphenous Vein Dual Antiplatelet Therapy

Interventions

DRUG

Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy

DRUG

Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy

DRUG

Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy

Inclusion Criteria: 1. Patients 18-80 of age. 2. Patients undergo planned CABG for the first time with ≥1 SVGs 3. Patients with written informed consent. Exclusion Criteria: 1. Patients undergoing concomitant valve surgery (excluding aortic bioprosthesis), aortic surgery, or rhythm surgery during the same session. 2. Patients undergoing emergency CABG. 3. Patients with single-vessel coronary artery disease. 4. Patients with cardiogenic shock or hemodynamic instability. 5. Patients with sick sinus syndrome, second- or third-degree atrioventricular block. 6. Patients with contraindications for coronary computed tomography angiography (CCTA) or coronary angiography, including contrast media allergy. 7. Patients requiring antiplatelet therapy other than aspirin or ticagrelor (e.g., clopidogrel, prasugrel) and unable to discontinue such medication after CABG, based on physician or investigator judgment. 8. Patients on oral anticoagulants before CABG who must continue anticoagulation therapy postoperatively. 9. Patients with contraindications for ticagrelor or aspirin, including: 9.1Bleeding diathesis within the past 3 months. 9.2Severe gastrointestinal bleeding within the past year. 9.3Peptic ulcer (even without bleeding) within the past 3 years. 9.4History of intracranial hemorrhage, aspirin allergy, or severe aspirin-induced gastrointestinal reaction. 10. Patients with a drug-eluting stent (DES) in a coronary or cerebral artery within 6 months before CABG, or a bare-metal stent (BMS) within 1 month before CABG. 11. Patients with thrombocytopenia (\<100 x 10⁹/L) before CABG. 12. Patients with severe renal dysfunction requiring dialysis or active liver disease, including unexplained persistent transaminase elevation or transaminase levels \>3× the upper normal limit. 13. Patients using strong CYP3A4 inhibitors. 14. Patients requiring methotrexate and ibuprofen therapy. 15. Patients with active malignant tumors with an increased risk of bleeding, as determined by the investigator. 16. Pregnant or breastfeeding women, and those who have given birth within the past 90 days. 17. Premenopausal women not using adequate contraception. Adequate contraception requires at least two reliable methods, including one barrier method.

Locations (1)

the Second Hospital of Jilin University

Changchun, Jilin, China

Clinical Research Directory

Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)